Progressive multifocal leukoencephalopathy after fingolimod treatment
Progressive multifocal leukoencephalopathy after fingolimod treatment
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DOI：
10.1212/wnl.0000000000005529
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发表时间：
2018-05-15
期刊：
影响因子：
9.9
通讯作者：
Merschhemke, Martin
中科院分区：
文献类型：
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作者：
Berger, Joseph R.;Cree, Bruce A.;Merschhemke, Martin
我们描述了15例芬戈莫德相关的进行性多灶性白质脑病（PML）患者的特征，这些患者是从诺华数据安全性数据库中确定的，并提供了该疾病的风险估计。PML分类基于先前发表的标准。使用15例确诊PML患者和接受fingolimod.ResultsAs的患者总体人群估计风险和发病率，截至2017年8月31日，15例接受fingolimod治疗的患者在前6个月内未接受那他珠单抗治疗的情况下发生PML。其中11人（73%）为女性，平均年龄为53岁（中位数：53岁）。15例患者中有14例接受芬戈莫德治疗超过2年。2例患者存在混杂医学状况。2例患者接受了那他珠单抗治疗。这包括1例患者，其末次那他珠单抗给药时间为PML诊断前3年9个月。第二名患者接受芬戈莫德治疗4年零6个月，中断治疗开始那他珠单抗治疗，并在开始那他珠单抗治疗3个月后诊断为PML。15名患者中有14名患者的淋巴细胞绝对计数可用，没有一名患者表现出持续的4级淋巴细胞减少症（
ObjectiveWe describe the characteristics of the 15 patients with fingolimod-associated progressive multifocal leukoencephalopathy (PML) identified from the Novartis data safety base and provide risk estimates for the disorder.MethodsThe Novartis safety database was searched for PML cases with a data lock point of August 31, 2017. PML classification was based on previously published criteria. The risk and incidence were estimated using the 15 patients with confirmed PML and the overall population of patients treated with fingolimod.ResultsAs of August 31, 2017, 15 fingolimod-treated patients had developed PML in the absence of natalizumab treatment in the preceding 6 months. Eleven (73%) were women and the mean age was 53 years (median: 53 years). Fourteen of the 15 patients were treated with fingolimod for >2 years. Two patients had confounding medical conditions. Two patients had natalizumab treatment. This included one patient whose last dose of natalizumab was 3 years and 9 months before the diagnosis of PML. The second patient was receiving fingolimod for 4 years and 6 months, which was discontinued to start natalizumab and was diagnosed with PML 3 months after starting natalizumab. Absolute lymphocyte counts were available for 14 of the 15 patients and none exhibited a sustained grade 4 lymphopenia (